CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Diet support group +1 morebehavioral
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Diagnosis of schizophrenia or schizoaffective disorder
  • ✓Currently taking olanzapine or clozapine for at least 6 months
  • ✓Weight gain of 7% over baseline or BMI ≥27
Key exclusion· 8
  • ✕Current use of methylphenidate, clonidine, tricyclic antidepressants, bupropion, or venlafaxine
  • ✕Other weight-gain-causing medications unless stable on medication for 6 months
  • ✕Other weight loss medications unless weight stable for 6 months
  • ✕Mental retardation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00176436
NCT00176436Phase 4Completed
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Double-Blind Study of Atomoxetine for Weight Management in Patients Taking Olanzapine or Clozapine

University of Maryland, Baltimore·interventional·Posted Sep 15, 2005·Updated Mar 14, 2022

In Brief

A Phase 4 clinical trial evaluating Diet support group and Group counseling and exercise for Schizophrenia. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The study investigates the use of Atomoxetine in combination with exercise and a diet support group (Weight Watchers)to treat weight gain associated with Olanzapine or clozapine. All patients must be adults who have been diagnosed with Schizophrenia or Schizoaffective Disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
CollaboratorsEli Lilly and Company

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartFeb 1, 2004
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.8 years ago

Interventions

Diet support groupbehavioral

Diet support group weekly and exercise sessions 3 times/week, placebo medication

Group counseling and exercisebehavioral

Support group weekly and exercise sessions 3 times/week for 24 weeks